The Effect of Intravenous Lidocaine on Pain After Thyroidectomy
Study Details
Study Description
Brief Summary
This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing thyroidectomy.
A total 56 patients will be randomized into one of two groups(group C or group I) based on Excel number generation.
Patients in group C will receive normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5mg/kg lidocaine followed by a continuous lidocaine infusion of 2mg/kg/hr.
Visual analogue scale pain scores, fentanyl consumption, the frequency at which patients pushed the button(FPB) of a patient-controlled analgesia system, and presence or absence of nausea and vomiting will be recorded at 2,4,8,12,24,48 hours postoperatively.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Intravenous lidocaine injection group Patients in Group I (intravenous lidocaine injection group) received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr. |
Drug: Intravenous lidocaine injection
Patients in Group I (intravenous lidocaine injection group) received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.
Other Names:
|
| Placebo Comparator: Placebo control group Patients in Group C (placebo control group) received normal saline intravenous injection |
Drug: Intravenous normal saline injection
The patients in Group C (placebo control group) received normal saline intravenous injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Postoperative pain measured using Visual analogue scale at postoperative 2hour [post op 2hour]
Patients will be assessed for pain using a visual analogue pain scale(VAS). It is usually a horizontal line, 100mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks ont the line the that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. To check the severity of pain VAS will be measured at post op 2hour.
Secondary Outcome Measures
- visual analogue scale 4hour [post op 4 hour]
Patients will be assessed for pain using a visual analogue pain scale(VAS). It is usually a horizontal line, 100mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks ont the line the that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. To check the severity of pain VAS will be measured at post op 4hour.
- visual analogue scale 8 hour [Post op 8 hour]
Patients will be assessed for pain using a visual analogue pain scale(VAS). It is usually a horizontal line, 100mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks ont the line the that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. To check the severity of pain VAS will be measured at post op 8hour.
- Visual analogue scale 12hour [Post op 12 hour]
Patients will be assessed for pain using a visual analogue pain scale(VAS). It is usually a horizontal line, 100mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks ont the line the that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. To check the severity of pain VAS will be measured at post op 12hour.
- visual analogue scale 24hour [Post op 24 hour]
Patients will be assessed for pain using a visual analogue pain scale(VAS). It is usually a horizontal line, 100mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks ont the line the that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. To check the severity of pain VAS will be measured at post op 24hour.
- visual analogue scale 48 hour [Post op 48hour]
Patients will be assessed for pain using a visual analogue pain scale(VAS). It is usually a horizontal line, 100mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks ont the line the that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. To check the severity of pain VAS will be measured at post op 48hour.
- Opioid consumption 2hour [post op 2hour]
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occured. In the case of persistent pain greater than a visual analogue scale(VAS) pain score of 30mm, and additional 50㎍ of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30mm. And sum of delivery from PCA system and and additional opioid fom immediately after operation to post op 2hour will be measured.
- Opioid consumption 4 hour [Post op 4 hour]
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occured. In the case of persistent pain greater than a visual analogue scale(VAS) pain score of 30mm, and additional 50㎍ of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30mm. And sum of delivery from PCA system and and additional opioid fom immediately after operation to post op 4hour will be measured
- Opioid consumption 8hour [Post op 8 hour]
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occured. In the case of persistent pain greater than a visual analogue scale(VAS) pain score of 30mm, and additional 50㎍ of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30mm. And sum of delivery from PCA system and and additional opioid fom immediately after operation to post op 8hour will be measured
- Opioid consumption 12 hour [Post op 12 hour]
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occured. In the case of persistent pain greater than a visual analogue scale(VAS) pain score of 30mm, and additional 50㎍ of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30mm. And sum of delivery from PCA system and and additional opioid fom immediately after operation to post op 12hour will be measured
- Opioid consumption 24 hour [Post op 24 hour]
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occured. In the case of persistent pain greater than a visual analogue scale(VAS) pain score of 30mm, and additional 50㎍ of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30mm. And sum of delivery from PCA system and and additional opioid fom immediately after operation to post op 24hour will be measured
- Opioid consumption 48 hour [Post op 48 hour]
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occured. In the case of persistent pain greater than a visual analogue scale(VAS) pain score of 30mm, and additional 50㎍ of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30mm. And sum of delivery from PCA system and and additional opioid fom immediately after operation to post op 48hour will be measured
- FPB 2hour [Post op 2 hour]
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 2 hour will be measured.
- FPB 4hour [Post op 4 hour]
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 4 hour will be measured.
- FPB 8 hour [Post op 8 hour]
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 8 hour will be measured.
- FPB 12 hour [Post op 12 hour]
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 12 hour will be measured.
- FPB 24hour [Post op 24hour]
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 24 hour will be measured.
- FPB 48 hour [Post op 48 hour]
The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 48 hour will be measured.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Total thyroidectomy
Exclusion Criteria:
-
mental change
-
allergy to local anesthetics
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ChungAng University | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Investigators
- Study Chair: Hyun Kang, Ph.D, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
- Principal Investigator: Eun Jin Ahn, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ChungAngUH3